NCT02386982已完成1 期
A Single-centre, Randomized, Open-label, 2-arm, 4-week Treatment Study to Investigate the Beta Cell Function and Related Pharmacodynamics in Type 2 Diabetes Mellitus (T2DM) Patients
Hua Medicine Limited1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- beta cell function
研究概览
简要总结
This study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and tolerability after 4 weeks treatment of 75mgBID or 75mgQD of HMS5552.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female,age 18-65 years
- •Has type 2 diabetes mellitus
- •BMI 20 to 29kg/m2
- •Willingness to adhere to the protocol requirement
排除标准
- •Patients with type1 diabetes mellitus
- •Received any antidiabetic drug within run-in or during screening
- •Hepatic diseases
- •Kidney diseases
- •Clinical abnormal finding in EVG,labs and physical exams
- •Women of child-bearing potential
研究组 & 干预措施
HMS5552 dose 1
Experimental
HMS5552 75mg.Oral administration,twice per day.
干预措施: HMS5552 (Drug)
HMS5552 dose 2
Experimental
HMS5552 75mg.Oral administration,once per day.
干预措施: HMS5552 (Drug)
结局指标
主要结局
beta cell function
时间窗: 4 weeks
will be assessed by change of beta cell function index
HbA1
时间窗: 4 weeks
24-hour glucose change
时间窗: 4 weeks
次要结局
- The study drug concentration in blood samples to be collected after drug administration(4 weeks)
- Composite measure of adverse events monitoring, physical examinations,12 lead ECGs, vital sign,and safety laboratory measurement(4 weeks)
研究者
研究点 (1)
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